Dynamic rod
A dynamic rod implantable into a patient and connectable between two vertebral anchors in adjacent vertebral bodies is provided. The dynamic rod fixes the vertebral bodies together in a dynamic fashion providing immediate postoperative stability and support of the spine. The dynamic rod comprises a first rod portion and a second rod portion connected together. The dynamic rod further includes at least a one bias element configured to provide a bias force in response to deflection or translation of the first rod portion relative to the second rod portion. The dynamic rod includes a locking construct which advantageously enables the extension and/or angulation of one rod portion with respect to the other rod portion to be reversibly locked in position. The dynamic rod permits relative movement of the first and second rod portions allowing the rod to carry some of the natural flexion and extension moments of the spine.
This application claims the benefit of and is a continuation-in-part of U.S. Provisional Patent Application Ser. No. 61/063,878 entitled “Dynamic rod” filed on Feb. 6, 2008 which is incorporated herein by reference in its entirety. This application is a continuation-in-part of U.S. patent application Ser. No. 12/233,212 entitled “Dynamic rod” filed on Sep. 18, 2008 incorporated herein by reference in its entirety which is a non-provisional of U.S. Provisional Patent Application Ser. No. 60/994,899 entitled “Dynamic rod” filed on Sep. 21, 2007 which is incorporated herein by reference in its entirety. This application also claims priority to and is a continuation-in-part of co-pending U.S. patent application Ser. No. 12/154,540 entitled “Dynamic rod” filed on May 23, 2008 which is a non-provisional of U.S. Provisional Patent Application Ser. No. 60/931,811 entitled “Dynamic rod” filed on May 25, 2007, all of which are hereby incorporated by reference in their entireties. This application also claims priority to and is a continuation-in-part of co-pending U.S. patent application Ser. No. 11/427,738 entitled “Systems and methods for stabilization of the bone structures” filed on Jun. 29, 2006 which is a contintuation-in-part of U.S. patent application Ser. No. 11/436,407 entitled “Systems and methods for stabilization of the bone structures” filed on May 17, 2006 which is a continuation-in-part of U.S. patent application Ser. No. 11/033,452 entitled “Systems and methods for stabilization of the bone structures” filed on Jan. 10, 2005 which is a continuation-in-part of U.S. patent application Ser. No. 11/006,495 entitled “Systems and methods for stabilization of the bone structures” filed on Dec. 6, 2004 which is a continuation-in-part of U.S. patent application Ser. No. 10/970,366 entitled “Systems and methods for stabilization of the bone structures” filed on Oct. 20, 2004. All of the above-referenced applications are each incorporated herein by reference in their entirety.
BACKGROUNDDamage to the spine as a result of advancing age, disease, and injury, has been treated in many instances by fixation or stabilization of vertebrae. Conventional methods of spinal fixation utilize a rigid spinal fixation device to support an injured spinal vertebra relative to an adjacent vertebra and prevent movement of the injured vertebra relative to an adjacent vertebra. These conventional spinal fixation devices include anchor members for fixing to a series of vertebrae of the spine and at least one rigid link element designed to interconnect the anchor members. Typically, the anchor member is a screw and the rigid link element is a rod. The screw is configured to be inserted into the pedicle of a vertebra to a predetermined depth and angle. One end of the rigid link element is connected to an anchor inserted in the pedicle of the upper vertebra and the other end of the rod is connected to an anchor inserted in the pedicle of an adjacent lower vertebra. The rod ends are connected to the anchors via coupling constructs such that the adjacent vertebrae are supported and held apart in a relatively fixed position by the rods. Typically two rods and two pairs of anchors are installed each in the manner described above such that two rods are employed to fix two adjacent vertebrae, with one rod positioned on each side of adjacent vertebrae. Once the system has been assembled and fixed to a series of two or more vertebrae, it constitutes a rigid device preventing the vertebrae from moving relative to one another. This rigidity enables the devices to support all or part of the stresses instead of the stresses being born by the series of damaged vertebra.
While these conventional procedures and devices have been proven capable of providing reliable fixation of the spine, the resulting constructs typically provide a very high degree of rigidity to the operative levels of the spine resulting in decreased mobility of the patient. Unfortunately, this high degree of rigidity imparted to the spine by such devices can sometimes be excessive. Because the patient's fixed vertebrae are not allowed to move, the vertebrae located adjacent to, above or below, the series that has undergone such fixation tend to move more in order to compensate for the decreased mobility. As a result, a concentration of additional mechanical stresses is placed on these adjacent vertebral levels and a sharp discontinuity in the distribution of stresses along the spine can then arise between, for example, the last vertebra of the series and the first free vertebra. This increase in stress can accelerate degeneration of the vertebrae at these adjacent levels.
Sometimes, fixation accompanies a fusion procedure in which bone growth is encouraged to bridge the intervertebral body disc space to thereby fuse adjacent vertebrae together. Fusion involves removal of a damaged intervertebral disc and introduction of an interbody spacer along with bone graft material into the intervertebral disc space. In cases where fixation accompanies fusion, excessively rigid spinal fixation is not helpful to the promotion of the fusion process due to load shielding away from the fixed series. Without the stresses and strains, bone does not have loads to adapt to and as bone loads decrease, the bone becomes weaker. Thus, fixation devices that permit load sharing and assist the bone fusion process are desired in cases where fusion accompanies fixation.
Various improvements to fixation devices such as a link element having a dynamic central portion have been devised. These types of dynamic rods support part of the stresses and help relieve the vertebrae that are overtaxed by fixation. Some dynamic rods are designed to permit axial load transmission substantially along the vertical axis of the spine to prevent load shielding and promote the fusion process. Dynamic rods may also permit a bending moment to be partially transferred by the rod to the fixed series that would otherwise be completely born by vertebrae adjacent to the fixed series. Compression or extension springs can be coiled around the rod for the purpose of providing de-rotation forces as well as relative translational sliding movement along the vertical axis of the spine. Overall, the dynamic rod in the fixation system plays an important role in recreating the biomechanical organization of the functional unit made up of two fixed vertebrae together with the intervertebral disc. In some cases or over time, a doctor may determine that it is best for the patient to substitute a rigid rod for a dynamic one or vice versa. No device currently on the market allows for the change without replacing the already imlanted rod. The present invention advantageously provides the doctor with an option to convert the same rod from a dynamic one to a rigid one and vice versa through a unique reversible locking mechanism that may be engaged percutaneously in a minimially invasive manner.
In conclusion, conventional spinal fixation devices have not provided a comprehensive solution to the problems associated with curing spinal diseases in part due to the difficulty of creating a system that mimics a healthy functioning spinal unit. Hence, there is a need for an improved dynamic spinal fixation device that provides a desired level of flexibility to the fixed series of the spinal column, while also providing long-term durability and consistent stabilization of the spinal column.
SUMMARYAccording to one aspect of the invention, a dynamic rod, implantable in a spine, comprises a first rod portion having a first engaging portion at a first end and a second rod portion having a second engaging portion at a first end. The first and second rod portions are connected to each other at the first and second engaging portions such that the first rod portion and second rod portion are capable of relative motion. The dynamic rod further includes a lock configured to lock said relative motion. In one variation of the dynamic rod, the lock is reversible. Generally, a bias element such as a spring is disposed between the first rod portion and the second rod portion to bias the movement of one rod portion relative to the other rod portion. In one variation, the dynamic rod is configured such that the relative motion is angulation of the first rod portion relative to the second rod portion. In another variation, the dynamic rod is configured such that the relative motion is longitudinal translation of the first rod portion relative to the second rod portion. In another variation, the dynamic rod is configured such that the relative motion is angulation of the first rod portion relative to the second rod portion and longtudinal translation of the first rod portion relative to the second rod portion. In one variation, the lock includes a spacer movable to a locked position between the first and second rod portions to arrest said relative motion. In another variation, the lock includes a ramp portion configured to provide ramp surface for the spacer to move against into a locked position. In a further variation, the spacer and ramp portion are located in the first engaging portion and the second rod portion is nested inside the first engaging portion such that when in the locked position the ramp portion abuts the first end of the second rod portion and the spacer abuts the ramp portion. In another variation, the dynamic rod includes an aperture for percutaneously engaging said lock.
According to another aspect of the invention, a dynamic rod, implantable in a spine, comprises a first rod portion coupled to a second rod portion and configured such that movement of one rod portion with respect to the other rod portion is lockable in position by a lock. In one variation, the movement is longitudinal translation or angulation of one rod portion with respect to the other rod portion. In another variation, the movement of one rod portion with respect to the other rod portion is reversibly lockable in position by the lock. In another variation, the longitudinal translation of the first rod portion with respect to the second rod portion is lockable by the lock while permitting the angulation of the first rod portion with respect to the second rod portion. In another variation, the angulation of one rod portion with respect to the other rod portion is lockable whereas the relative longitudinal translation is permitted. In one variation, the distance of the first rod portion from the second rod portion is lockable at any location within the range of motion. In another variation, the rod is lockable in a position such that the first rod portion is fully extended from the second rod portion. In another variation the lock operates such that the rod is lockable in a position such that the first rod portion is angled with respect to the second rod portion. In another variation, the lock operates such that the rod is lockable in a position such that the first rod portion is fully compressed towards the second rod portion. In one variation, the lock comprises an element movable in a substantially transverse direction to the longitudinal axis of the rod to a locked position. In another variation, the dynamic rod includes a spring disposed between the first and second rod portions.
Referring now to
A typical anchor system comprises, but is not limited to, a spinal bone screw 22 that is designed to have one end that inserts threadably into a vertebra and a seat 24 at the opposite end thereof. Typically, the seat 24 is designed to receive the link element 10a, 20b in a channel 26 in the seat 24. The link element 10a, 10b is typically a rod or rod-like member. The seat 24 typically has two upstanding arms that are on opposite sides of the channel that receives the rod member 10a, 10b. The rod 10a, 10b is laid in the open channel which is then closed with a closure member 28 to both capture the rod 10a, 10b in the channel 26 and lock it in the seat 24 to prevent relative movement between the seat 24 and the rod 10a, 10b. A multi-level installation is shown in
With particular reference to
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The second rod portion 14 further includes a bore opening at the first end 36 defining a bias element receiving portion 112 configured and sized to receive at least a portion of the bias element 16 therein.
Still referencing
The anchor connecting portion 44 is sized and configured to be seated in a channel of a seat of a bone screw anchor for example. Any configuration for the second end 38 that is suitable for connection to an anchor is within the scope of the present invention and, for example, may include a rotatable pin-and-slot or other configuration similar to that shown in
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After the dynamic rod 10 is assembled, it is ready to be implanted within a patient and be connected to anchors planted in pedicles of adjacent vertebral bodies preferably in a manner such that the first rod portion 12 of the dynamic rod 10 is oriented cephalad and connected to the upper anchor and the second rod portion 14 is placed caudad and connected to the lower anchor. Because the first rod portion 12 includes an anchor connecting portion 22 configured such that connection with the anchor does not result in the rod extending cephalad beyond the anchor, this orientation and configuration of the dynamic rod is advantageous particularly because it avoids impingement of adjacent anatomy in flexion or in extension of the spine of the patient.
In an alternative variation, the dynamic rod 10 is implanted into the patient such that the first rod portion 12 is oriented caudad and the second rod portion 14 is oriented cephalad. In this variation, the second rod portion 14 includes an anchor connecting portion 44 that is partially spherical in shape and includes oppositely disposed outwardly extending pins 54 for engaging slots formed in the upper anchor to allow the dynamic rod 10 to pivot about pins 54 when connected to the anchor. Of course any connection means is permitted and not limited to a pin-slot engagement. The anchor connecting portion 44 may also include oppositely disposed flat areas 56 as described above. The second rod portion 14 of the dynamic rod 10 is oriented cephalad and connected to the upper anchor and the first rod portion 12 is placed caudad and connected to the lower anchor. Because the second rod portion 14 includes an anchor connecting portion 44 configured such that connection with the anchor does not result in excessive rod extending cephalad beyond the anchor, this orientation and configuration of the dynamic rod is advantageous particularly because it avoids impingement of adjacent anatomy in flexion or in extension of the spine of the patient.
Therefore, it is noted that the preferred implantation method and preferred orientation of the dynamic rod 10 is such that there is minimal or substantially no “overhanging” rod extending cephalad beyond the upper anchor. Such orientation is achieved by the orientation of the rod during implantation as well as by the configuration of the anchor connecting portion 22, 44 of either one or both of the first rod portion 12 and second rod portion 14 such that the anchor connecting portion 22, 44 is configured such that there is substantially no or little overhang beyond the anchor.
The implanted dynamic rod and anchor system fixes the adjacent vertebral bodies together in a dynamic fashion providing immediate postoperative stability and support of the spine. Still referencing
Angle “A” is approximately between zero and ten degrees, preferably approximately five degrees with respect to the longitudinal axis “x” in a polyaxial direction from the longitudinal axis “x”.
Hence,
In one variation, the bias element 16 is a compression spring that becomes shorter when axially loaded and acts as an extension mechanism such that when disposed in the assembled dynamic rod 10 and axially loaded, the bias element 16 exerts a biasing force pushing the first rod portion 12 and the second rod portion 14 apart. In one variation, the bias element 16 is configured such that it exerts a biasing force pushing the first rod portion 12 and second rod portion 14 apart by the maximum degree permitted by the dynamic rod configuration such that when longitudinally loaded the second rod portion 14 will move inwardly towards the first rod portion 12 and the bias element will tend to push the second rod portion 14 outwardly.
In another variation, the bias element 16 is a coil configured to not exhibit spring-like characteristics when loaded along the longitudinal axis. Instead, the coil serves a stabilizer for loads having a lateral force component, in which case the lateral biasing is provided by the bias element.
Another advantageous feature of the dynamic rod 10 according to the present invention is that it can be locked. In one variation, the dynamic rod 10 according to the present invention can be locked in extension. Turning now to
The disclosed devices or any of their components can be made of any biologically adaptable or compatible materials including PEEK, PEK, PAEK, PEKEKK or other polyetherketones. Materials considered acceptable for biological implantation are well known and include, but are not limited to, stainless steel, titanium, tantalum, combination metallic alloys, various plastics, polymers, resins, ceramics, biologically absorbable materials and the like. Any components may be also coated with various coatings or made with osteo-conductive (such as deminerized bone matrix, hydroxyapatite, and the like) and/or osteo-inductive (such as Transforming Growth Factor “TGF-B,” Platelet-Derived Growth Factor “PDGF,” Bone-Morphogenic Protein “BMP,” and the like) bio-active materials that promote bone formation as well as with anti-microbial materials. Further, a surface of any of the implants may be made with a porous ingrowth surface (such as titanium wire mesh, plasma-sprayed titanium, tantalum, porous CoCr, and the like), provided with a bioactive coating, made using tantalum, and/or helical rosette carbon nanotubes (or other carbon nanotube-based coating) in order to promote bone ingrowth or establish a mineralized connection between the bone and the implant, and reduce the likelihood of implant loosening. Lastly, any assembly or its components can also be entirely or partially made of a shape memory material or other deformable material. Of course, the second rod portion 14 and/or first rod portion 12 may be slightly curved to provide an overall curved rod 10 for conforming to patient anatomy and, of course, the rod 10 may be substantially straight.
From the above, it is evident that the present invention can be used to relieve pain caused by spinal stenosis in the form of, by way of example only, central canal stenosis or foraminal stenosis, degenerative disc disease, spondylolisthesis, spinal deformaties, fracture, pseudarthrosis and tumors.
All publications mentioned herein are incorporated herein by reference to disclose and describe the methods and/or materials in connection with which the publications are cited. The preceding illustrates the principles of the invention. It will be appreciated that those skilled in the art will be able to devise various arrangements which, although not explicitly described or shown herein, embody the principles of the invention and are included within its spirit and scope.
Claims
1. A dynamic rod implantable in a spine comprising:
- a first rod portion having a first engaging portion at a first end;
- a second rod portion having a second engaging portion at a first end, the first and second rod portions connected to each other at the first and second engaging portions such that the first rod portion and second rod portion are capable of relative motion; and
- a lock configured to lock said relative motion.
2. The dynamic rod of claim 1 wherein the lock is reversible.
3. The dynamic rod of claim 1 further including a bias element disposed between the first rod portion and the second rod portion.
4. The dynamic rod of claim 1 wherein said relative motion is angulation of the first rod portion relative to the second rod portion or longitudinal translation of the first rod portion relative to the second rod portion.
5. The dynamic rod of claim 1 wherein said relative motion is angulation of the first rod portion relative to the second rod portion and longtudinal translation of the first rod portion relative to the second rod portion.
6. The dynamic rod of claim 1 wherein the lock includes a spacer movable to a locked position between the first and second rod portions to arrest said relative motion.
7. The dynamic rod of claim 6 wherein the lock includes a ramp portion configured to provide ramp surface for the spacer to move against into a locked position.
8. The dynamic rod of claim 7 wherein the spacer and ramp portion are located in the first engaging portion and the second rod portion is nested inside the first engaging portion; wherein when in the locked position the ramp portion abuts the first end of the second rod portion and the spacer abuts the ramp portion.
9. The dynamic rod of claim 1 further including an aperture for percutaneously engaging said lock.
10. A dynamic rod implantable in a spine comprising:
- a first rod portion coupled to a second rod portion and configured such that movement of one rod portion with respect to the other rod portion is lockable in position by a lock.
11. The dynamic rod of claim 10 wherein the movement is longitudinal translation or angulation of one rod portion with respect to the other rod portion.
12. The dynamic rod of claim 10 wherein the movement of one rod portion with respect to the other rod portion is reversibly lockable in position by the lock.
13. The dynamic rod of claim 10 wherein the longitudinal translation of one rod portion with respect to the other rod portion is lockable by the lock while permitting the angulation of one rod portion with respect to the other rod portion.
14. The dynamic rod of claim 10 wherein the angulation of one rod portion with respect to the other rod portion is lockable by the lock while permitting the longitudinal translation of one rod portion with respect to the other rod portion.
15. The dynamic rod of claim 10 wherein the first rod portion is lockable at any distance from the second rod portion.
16. The dynamic rod of claim 10 wherein the rod is lockable in position such that the first rod portion is fully extended from the second rod portion.
17. The dynamic rod of claim 10 wherein the rod is lockable in position such that the first rod portion is angled with respect to the second rod portion.
18. The dynamic rod of claim 10 wherein the rod is lockable in position such that the first rod portion is fully compressed towards the second rod portion.
19. The dynamic rod of claim 10 wherein the lock comprises an element movable transversely to the longitudinal axis of the rod to a locked position.
20. The dynamic rod of claim 10 further including a spring disposed between the first and second rod portions.
Type: Application
Filed: Feb 5, 2009
Publication Date: Sep 10, 2009
Inventors: Stanley Kyle Hayes (Mission Viejo, CA), Joey Camia Reglos (Lake Forest, CA), Moti Altarac (Irvine, CA), Daniel H. Kim (Houston, TX)
Application Number: 12/366,089
International Classification: A61B 17/70 (20060101);